UltraShape Power in Combination With U-sculpt-n Transducer

Circumference Reduction Clinical Trial

Official title:

Clinical Evaluation of UltraShape Power System in Conjunction With the U-Sculpt-N Transducer for Non-invasive Circumference Reduction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02956720
• Other study ID #: DHF21321
• Status: Recruiting
• Phase: N/A
• First received: October 30, 2016
• Last updated: July 30, 2017
• Start date: January 2017
• Est. completion date: October 2018

Study information

• Verified date: July 2017
• Source: Syneron Candela
• Contact: Ketty Shkolnik, Ph.D.
• Phone: +972-73-2442268
• Email: kettys[@]syneron-candela.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective, open label, self - controlled, single arm, clinical study to assess the performance of the UltraShape Power using the U-Sculpt-N on outer thigh and/or flank for circumference reduction versus self-control.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: October 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Subject =18 and =60 years of age at the time of enrollment

2. Fat thickness of at least 1.5 cm in the outer thigh and/or flank (measured by calibrated caliper)

3. For women of child-bearing potential: negative urine pregnancy test

4. General good health confirmed by medical history and skin examination of the treated area

5. Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed.

Exclusion Criteria:

1. History of un-balanced hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator

2. Current hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease

3. Having a permanent implant in the treated area, such as metal plates, or an injected chemical substance such as silicone

4. Previous liposuction in the treatment areas within 12 months

5. History of skin disease in the treatment area, known tendency to form keloids or poor wound healing

6. Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood count within the last 3 months

7. Childbirth within the last 12 months or women who are breastfeeding a child

Related Conditions & MeSH terms

• Circumference Reduction

Intervention

Device:
• UltraShape Power
non-invasive body contouring procedure

Locations

Country	Name	City	State
Israel	Beit Noah	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Syneron Candela

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Outer thigh circumference reduction	To evaluate circumference reduction of outer thigh post treatment with UltraShape Power device used with the U-Sculpt-N transducer versus control side.	up to 24 week
Primary	Treatment-related adverse events	The frequency and severity of all treatment-related adverse events during and after using the UltraShape Power device used with the U-Sculpt-N transducer.	up to 24 week
Secondary	Subject satisfaction questionnaire	The assessment of subject satisfaction with treatment will be recorded during relevant visits (starting following the first treatment) using a 5-point Likert scale	up to 24 week